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临床试验/NCT01205555
NCT01205555终止不适用

Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles

Clinique Ovo2 个研究点 分布在 1 个国家目标入组 367 人开始时间: 2010年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
367
试验地点
2
主要终点
pregnancy rate

研究概览

简要总结

Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one of the most commonly used treatments for infertility. Accurate timing of insemination, in order to coincide with ovulation, has an important impact on the success rate. Optimal timing of insemination is achieved either by monitoring follicular growth through serial ultrasound measurements followed by the administration of human chorionic gonadotropin (hCG) or by the detection of urinary luteinizing hormone (LH). However in cycles where follicular growth is monitored there is a possibility of premature LH rise before the administration of hCG, which may affect the outcome of the treatment. The goal of the study is to determine if adding the testing of urine LH in conjunction with ultrasound monitoring leads to an increase in pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing IUI treatments for:
  • Unexplained infertility (including endometriosis stage 1-2)
  • Mild male factor (>5x106/ml motile sperm as determined by total sperm concentration x % A+B motility in the latest spermogram)
  • Donor insemination
  • Natural or stimulated cycles with clomiphene citrate or letrozole
  • At least 1 patent tube on hysterosalpingogram, hysterosonogram or laparoscopy within the last two years
  • Antral follicular count ≥10 and FSH<10

排除标准

  • Polycystic ovarian syndrome or any cause of oligo or anovulation
  • Patients taking other infertility medication (metformin, 17B estradiol, progesterone or gonadotropins)
  • Presence of an ovarian cyst or a follicle >20 mm on the first ultrasound or any reason for immediate HCG administration
  • A previous sperm washing result with less than 5x106/ml motile sperm
  • Previous inconclusive uLH test or inability to perform uLH testing

研究组 & 干预措施

ultrasound alone group

No Intervention

Patients in the control group will have a standard ultrasound monitoring with HCG administered when the leading follicle reaches 18 mm, and IUI 36 h afterward.

LH testing combined with ultrasound monitoring

Experimental

干预措施: urine LH testing (Device)

结局指标

主要结局

pregnancy rate

时间窗: 14 days post IUI

as defined by positive urine pregnancy test

次要结局

  • rate of positive LH testing(before hCG administration)

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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